The DOI matches its Crossref record, with a small difference in title or year; 69 of the 70 references it cites were found in a registry or an index.
False Alarms and Pseudo-Epidemics: The Limitations of Observational Epidemiology
Abstract
Most reported associations in observational clinical research are false, and the minority of associations that are true are often exaggerated. This credibility problem has many causes, including the failure of authors, reviewers, and editors to recognize the inherent limitations of these studies. This issue is especially problematic for weak associations, variably defined as relative risks (RRs) or odds ratios (ORs) less than 4. Such associations, commonly reported in the medical literature, are more likely to be attributable to bias than to causal association. All observational research has bias (which can include selection, information, and confounding bias). Hence, detection of small associations falls below the discriminatory ability of observational studies. In general, unless RRs in cohort studies exceed 2 to 3 or ORs in case-control studies exceed 3 or 4, associations in observational research findings should not be considered credible. However, these guidelines are not foolproof: strong (yet spurious) associations can result when large amounts of bias are present. Only in a properly performed randomized controlled trial, free of bias, should small associations merit attention. Better training and more circumspection on the part of investigators, tougher editorial standards on the part of journals, and hefty skepticism on the part of referees and readers are necessary to avoid the dangers of false alarms, pseudo-epidemics, and their unfortunate consequences.
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“In accordance with recommendations of Grimes and Schultz (23), we considered odds ratios to be clinically significant only if they were greater than 3.5 or 4.”
From Urinary incontinence and disability in community-dwelling women: A cross-sectional study: Urinary Incontinence and Disability in Ambulatory Women (2015) · cites this paper as [23]
Citations
Cites
von Elm, E., Altman, D. G., Egger, M., Pocock, S. J., Gøtzsche, P. C., Vandenbroucke, J. P., & Initiative, F. T. S. (2007) · PLoS Medicine · doi:10.1371/journal.pmed.0040296 · Cited by 23,020
von Elm, E., Altman, D. G., Egger, M., Pocock, S. J., Gøtzsche, P. C., & Vandenbroucke, J. P. (2007) · The Lancet · doi:10.1016/s0140-6736(07)61602-x · Cited by 21,320
CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
the CONSORT Group, Schulz, K. F., Altman, D. G., & Moher, D. (2010) · BMC Medicine · doi:10.1186/1741-7015-8-18 · Cited by 13,371
Self-citationWhy Most Published Research Findings Are False
Ioannidis, J. P. A. (2005) · PLoS Medicine · doi:10.1371/journal.pmed.0020124 · Cited by 10,505
CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
Schulz, K. F., Altman, D. G., Moher, D., & for the CONSORT Group (2010) · BMJ · doi:10.1136/bmj.c332 · Cited by 9,329
Self-citationThe environment and disease: association or causation?
Hill, A. B. (2015) · Journal of the Royal Society of Medicine · doi:10.1177/0141076814562718 · Cited by 7,804
The Environment and Disease: Association or Causation?
Hill, A. B. (1965) · Proceedings of the Royal Society of Medicine · doi:10.1177/003591576505800503 · Cited by 6,974
von Elm, E., Altman, D. G., Egger, M., Pocock, S. J., Gøtzsche, P. C., & Vandenbroucke, J. P. (2007) · Preventive Medicine · doi:10.1016/j.ypmed.2007.08.012 · Cited by 2,698
Sackett, D. L. (1979) · Journal of Chronic Diseases · doi:10.1016/0021-9681(79)90012-2 · Cited by 2,075
Bias and causal associations in observational research
Grimes, D. A., & Schulz, K. F. (2002) · The Lancet · doi:10.1016/s0140-6736(02)07451-2 · Cited by 1,553
Self-citation
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Collins, R., Reith, C., Emberson, J., Armitage, J., Baigent, C., Blackwell, L., Blumenthal, R., Danesh, J., Smith, G. D., DeMets, D., et al. (2016) · The Lancet · doi:10.1016/s0140-6736(16)31357-5 · Cited by 1,857
Self-citationACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease
Katz, P. O., Dunbar, K. B., Schnoll‐Sussman, F. H., Greer, K. B., Yadlapati, R. H., & Spechler, S. J. (2021) · The American Journal of Gastroenterology · doi:10.14309/ajg.0000000000001538 · Cited by 1,064
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Prevalence and Trends of Symptomatic Pelvic Floor Disorders in U.S. Women
Wu, J. M., Vaughan, C. P., Goode, P. S., Redden, D. T., Burgio, K. L., Richter, H. E., & Markland, A. D. (2013) · Obstetrics and Gynecology · doi:10.1097/aog.0000000000000057 · Cited by 947
Complications of Proton Pump Inhibitor Therapy
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Metadata
- Authors
- Grimes, D. A., & Schulz, K. F.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Venue
- Obstetrics & Gynecology
- Published
- 2012-10
- Volume
- 120
- Issue
- 4
- Pages
- 920-927
- ISSN
- 0029-7844 (ISSN-L)
- OpenAlex
- W2130635109
- Cited by
- 254
- References
- 70
- Citations by year
- 2026: 5 · 2025: 13 · 2024: 14 · 2023: 13 · 2022: 17 · 2021: 23 · 2020: 27 · 2019: 18 · 2018: 30 · 2017: 19 · 2016: 18 · 2015: 25 · 2014: 19 · 2013: 10 · 2012: 2
- FWCI
- 17.14
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Obstetrics and Gynecology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- false alarms, weak associations, spurious association, bias in observational studies, confounding, selection bias, information bias, relative risk, odds ratio, editorial standards, peer review, randomized controlled trials
- MeSH terms
- Data Interpretation, Statistical, Risk, Reproducibility of Results, Cohort Studies, Bias, Causality, Odds Ratio, Case-Control Studies, Observation
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